To address this latest safety concern, the third in three months, the company is updating each device and then returning it to the customer.

Some controllers were assembled with an incorrect part, potentially impacting device performance. The FDA shared an early alert about this issue in August. It has been linked to one patient's death. 

An updated version of Heartflow's Plaque Analysis platform has gained FDA clearance. In addition, the company announced that Cigna will cover the platform going forward.

The U.S. Food and Drug Administration sent a letter to physicians Monday, urging them to consider the risks associated with maternal use of acetaminophen, which it said includes the development of autism or ADHD. However, the agency admitted a "causal relationship has not been established."

Siemens Healthineers and Styker are collaborating on a brand new robotic system that can perform a variety of neurovascular procedures.

Approximately one in four Americans will develop heart failure in their lifetime, according to a new report from the Heart Failure Society of America. What can be done to combat this worrisome trend?

It's still early, but a new feature could provide significant value when electrophysiologists use augmented reality during ablation procedures. 

The new initiative aims to provide shock teams with objective data that can guide early management decisions and reduce mortality rates.